Because the FDA doesn’t recognize results from clinical trials conducted overseas, all the experiments done in India must be replicated in the US with larger sample sizes and with stricter guidelines for trial duration. Animal trials run anywhere from $200,000 to $300,000 a pop and, should the FDA permit clinical trials to take place in humans, “the next steps are millions of dollars,” Lissner said.
Between $5 to $10 million, to be more precise. While this project seems ideal for a large humanitarian organization to back, the response has been lukewarm. Lissner said that representatives of the Bill and Melinda Gates Foundation, for example, “don’t see the point in the male version” because their primary focus in contraceptives is options for women in developing nations. ” The science of contraception for men is less advanced, as is the proof of concept for men using contraception in the poorest countries of the world,” said Kellie Sloan, director of family planning at the Foundation, in a statement to Motherboard.
Count big pharma out as well—unlike big-ticket products, Vasalgel doesn’t have the ability to make the money back since it’s a one-time procedure using materials that are relatively inexpensive to make and distribute. Lissner pointed out that if the average person hits puberty at 13, and doesn’t want to have a kid until they’re in their mid-30s, that’s more than 20 years worth of contraception from which pharmaceutical companies can profit.
“The big pharma companies like drugs that people will take for years and years, that they have to take every day,” Sokal said. By contrast, the makers of RISUG have bragged that it costs less than the syringe used to inject it; Vasalgel would cost less than your typical $800 IUD.
“[Pharmaceutical companies] have a target that if they can’t make $500 million a year on a new drug, it’s not worth their time and energy to invest in it,” Sokal said, citing his conversations with pharmaceutical reps. By that estimate, it would take 625,000 injections a year to be of interest to big pharma—which is about 125,000 more procedures than there are annual vasectomies in the US.
FK – I’d have been interested 30 years ago. There were always three words that struck fear in my heart: ‘child support court.’
Once proven ‘safe’ this should be done to every 14-year-old male, not mandatory, but at an affordable price. How much would we save in ‘entitlements.’ Oh, I forgot, when ‘they’ birthed the welfare state they knew full well what the outcome would be: generational constituents.
Now we need to get to work on gene therapy or whatever it would be called, so that no one has to be born ugly or disabled in some way. Yes we can, probably preferably through a mostly ‘free market’ while finding a way to deal with the runaway greed that seems to infect the drug industry.